Esteem® Personal Programmer 908001-101

GUDID 00812282020078

Personal Programmer Model 8001

Envoy Medical Corporation

Fully-implantable middle ear implant system Fully-implantable middle ear implant system

• Primary Device ID: 00812282020078
• NIH Device Record Key: 5826caf8-173c-4851-9f32-d49e91d8e9f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esteem® Personal Programmer
• Version Model Number: 8001
• Catalog Number: 908001-101
• Company DUNS: 939725313
• Company Name: Envoy Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6513618000
• Email: info@envoymedical.com
• Phone: 6513618000
• Email: info@envoymedical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812282020078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P090018

FDA Product Code

• OAF: Implant, Hearing, Active, Middle Ear, Totally Implanted

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

Devices Manufactured by Envoy Medical Corporation

• 00812282020009 - Esteem® Sensor: 2018-12-21 Sensor Model 7010, IS-1 Connector
• 00812282020016 - Esteem® Driver: 2018-12-21 Driver Model 7504, IS-1 Connector
• 00812282020023 - Esteem® Driver: 2018-12-21 Driver Model 7504, IS-1 Connector
• 00812282020030 - Esteem® Driver: 2018-12-21 Driver Model 7510, IS-1 Connector
• 00812282020047 - Esteem® Sensor: 2018-12-21 Sensor Model 7004, IS-1 Connector
• 00812282020054 - Esteem® Sensor: 2018-12-21 Sensor Model 7004, IS-1 Connector
• 00812282020207 - Esteem® Sound Processor: 2018-12-21 Sound Processor Model 2001, IS-1 Connector Ports
• 00812282020214 - Esteem® Sound Processor: 2018-12-21 Sound Processor Model 2001, IS-1 Connector Ports